Trial of Pistachio Consumption in Older Adults

NCT ID: NCT06992544

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-06-30

Brief Summary

The goal of this study is to evaluate whether a pistachio-enriched diet leads to changes in cognitive function, cardiometabolic risk factors, and life satisfaction in older adults over a 6-month period.

Detailed Description

In this remote-based, parallel-arm RCT, the investigators will recruit participants from the recently completed COcoa Supplement and Multivitamin Outcomes Study (COSMOS) trial cohort. Eligible COSMOS participants will be invited to participate in the proposed RCT, screened to verify eligibility and willingness to participate, and asked to provide informed consent. Eligible and willing participants will be enrolled and randomized on a rolling basis. Risk factors and Outcome assessments will be conducted at baseline, 3 months and 6 months via the MyCap Mobile Toolbox application, REDCap questionnaires (for life satisfaction, dietary, and other phenotypic assessments), or at a local Quest Diagnostics (for biospecimen collection and return to our biorepository).

Conditions

Cognition; Cardiometabolic Risk Factors; Life Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pistachio-enriched diet

1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels

Group Type: ACTIVE_COMPARATOR

Pistachio-enriched diet

Intervention Type: OTHER

1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels

Usual diet

Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week)

Group Type: OTHER

Usual diet

Intervention Type: OTHER

Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week)

Interventions

Pistachio-enriched diet

1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels

Intervention Type: OTHER

Usual diet

Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Active participant in COSMOS

2. Current age 65 to 80 years

3. Does not reside in the states of Arizona, Hawaii, or Wyoming (since Quest Diagnostics does not have locations in these states)

Exclusion Criteria

1. Tree nut allergy

2. Current intake of pistachios, peanuts, walnuts, or other nuts >1 serving/week

3. Diagnosis of Alzheimer's disease or any other type of dementia

4. Diagnosis of cancer or CVD (MI, stroke, CABG, PTCA, or stent) within last 12 months

5. Changes in the dose or number of anti-hypertensive, lipid-lowering, or diabetic medications over the past 3 months prior to randomization

6. Does not own a smartphone or tablet

7. Unable or unwilling to abstain from pistachio intake for 6 months

8. Unable or unwilling to limit nut consumption to ≤1 serving/week for 6 months

9. Unable or unwilling to complete online questionnaires and cognitive assessments

10. Unable or unwilling to travel to a local Quest site for biospecimen collection

11. Unable or unwilling to provide consent to participate in the trial

12. Failure to complete the baseline Life Satisfaction Questionnaire

13. Failure to complete the baseline cognitive assessments

14. Failure to complete the baseline biospecimen collection

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Pistachio Growers

OTHER

Sponsor Role: collaborator

Boston Children's Hospital, Boston, MA, USA

OTHER

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: collaborator

Quest Diagnostics-Nichols Insitute

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Howard D. Sesso, ScD, MPH

Associate Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2024P002479

Identifier Type: -

Identifier Source: org_study_id